Jonathan D. Alpern

High-Cost Generic Drugs — Implications for Patients and Policymakers

Some older generic drugs have become very expensive, owing to factors including drug shortages, supply disruptions, and consolidations in the generic-drug industry. But generics manufacturers that legally obtain a market monopoly can also unilaterally raise prices.

Personal protection measures against mosquitoes, ticks, and other arthropods.

Arthropod-associated diseases are a major cause of morbidity among travelers. Obtaining a detailed travel itinerary and understanding traveler-specific and destination-specific risk factors can help mitigate the risk of vector-borne diseases. DEET, picaridin, PMD, and IR3535 are insect repellents that offer sufficient protection against arthropod bites. IR3535 does not provide adequate protection against Anopheles mosquitoes, and should be avoided in malaria-endemic regions. General protective measures, such as bite avoidance, protective clothing, insecticide-treated bed nets, and insecticide-treated clothing, should be recommended, especially in malaria-endemic areas. Spatial repellents may prevent nuisance biting, but have not been shown to prevent against vector-borne disease.

Essential medicines in the United States - Why access is diminishing

Prices have been dramatically increasing for many older, off-patent drugs, some of which are considered “essential” by the World Health Organization. Some price hikes have made potentially life-saving therapies unavailable to disadvantaged patients in the United States.

Ozena in Immigrants of Differing Backgrounds

Ozena, or atrophic rhinitis, is a chronic nasal process seen in Africa, India, and the Middle East. It is marked by the triad of fetid nasal discharge, crusting, and atrophy, and is often associated with Klebsiella infection. We present cases of ozena with nasal Klebsiella in three unrelated patients, including two east African children and one Saudi adult. All three patients grew Klebsiella species in culture and required prolonged treatment with multiple methodologies, including antibiotics, saline rinses, and surgical debridement. They differed greatly in time from presentation to diagnosis, and demonstrated various stages of the disease process. Ozena is rarely seen in the United States, and when it is seen, it is often misdiagnosed. Lack of prompt, adequate treatment can lead to long-term sequelae such as obliteration of nasal architecture, anosmia, sinus and skull base destruction, and social disenfranchisement due to the extreme foul smell of the nasal discharge. Clinicians should maintain a high index of suspicion for primary atrophic rhinitis when presented with its classic symptoms. Culture-directed and prolonged therapy with appropriate follow-up is a necessary component of a successful treatment plan.

Trends in Pricing and Generic Competition Within the Oral Antibiotic Drug Market in the United States

Background In recent years, the price of many older generic drugs, including numerous antibiotics, has increased substantially. We sought to analyze recent price changes and extent of generic competition within a cohort of commonly prescribed off-patent oral antibiotics. Methods We extracted oral antibiotics recommended for common outpatient conditions in the Infectious Diseases Society of America Practice Guidelines. We determined all US Food and Drug Administration-approved manufacturers for each formulation and strength in 2013 and 2016 and the yearly national average drug acquisition cost (NADAC) price between 2013 and 2016. Wilcoxon signed rank test was used to compare changes in drug prices and number of manufacturers from 2013 to 2016. Spearman correlation coefficient was used to assess the association between drug prices and number of manufacturers. Results Twenty-two antibiotics (81 formulations and strengths) were analyzed. There was no change in the median NADAC price or the number of manufacturers between 2013 and 2016. However, 11 (14%) formulations increased in price by 90% or more, and 13 (16%) had 2 or fewer manufacturers during all 4 years. Antibiotic prices were negatively associated with the number of available manufacturers. Conclusions While prices and the number of manufacturers for common oral antibiotics were overall stable between 2013 and 2016, reduced manufacturer competition was associated with increased prices. A subset of antibiotics exhibited substantial price increases, and most, but not all, had limited manufacturer competition. Policy solutions are needed to ensure availability of low-cost, essential generic antibiotics.

Diagnostic Delay and Antibiotic Overuse in Acute Pulmonary Blastomycosis

The diagnosis of blastomycosis is often delayed. We identified 28 cases of pulmonary blastomycosis in a retrospective chart review. Most patients received multiple antibiotic courses before being diagnosed, and the sputum KOH smear was rarely used. Diagnostic delay can be decreased with higher suspicion for pulmonary blastomycosis and early use of the sputum KOH smear.

Strongyloides hyperinfection following hematopoietic stem cell transplant in a patient with HTLV‐1‐associated T‐cell leukemia

Strongyloides stercoralis has the potential to cause accelerated autoinfection in immunocompromised hosts. Screening tests for strongyloidiasis may be falsely negative in the setting of immunosuppression. We report a case of Strongyloides hyperinfection syndrome in a patient with human T‐lymphotropic virus type 1‐associated T‐cell leukemia early after hematopoietic stem cell transplant. The diagnosis was made by stool ova and parasite examination, despite a negative screening enzyme‐linked immunosorbent assay. Because of anticipated prolonged neutropenia, an extended course of treatment was utilized.

Minocycline-induced skin hyperpigmentation

A 67-year-old male with rheumatoid arthritis and recurrent left prosthetic knee infection due to methicillin-resistant Staphylococcus aureus presented to the clinic. He had been taking minocycline 100 mg orally twice a day for the previous 16 months as chronic suppressive therapy. On physical examination, multiple new bluish-grey macules and patches were seen on bilateral forearms and legs (figures 1 and 2). We diagnosed the patient with an unusually severe form of type II minocycline-induced hyperpigmentation. The patient was not on any other medications known …

Access to benznidazole for Chagas disease in the United States-Cautious optimism?

Drugs for neglected tropical diseases (NTD) are being excessively priced in the United States. Benznidazole, the first-line drug for Chagas disease, may become approved by the Food and Drug Administration (FDA) and manufactured by a private company in the US, thus placing it at risk of similar pricing. Chagas disease is an NTD caused by Trypanosoma cruzi; it is endemic to Latin America, infecting 8 million individuals. Human migration has changed the epidemiology causing nonendemic countries to face increased challenges in diagnosing and managing patients with Chagas disease. Only 2 drugs exist with proven efficacy: benznidazole and nifurtimox. Benznidazole has historically faced supply problems and drug shortages, limiting accessibility. In the US, it is currently only available under an investigational new drug (IND) protocol from the CDC and is provided free of charge to patients. However, 2 companies have stated that they intend to submit a New Drug Application (NDA) for FDA approval. Based on recent history of companies acquiring licensing rights for NTD drugs in the US with limited availability, it is likely that benznidazole will become excessively priced by the manufacturer—paradoxically making it less accessible. However, if the companies can be taken at their word, there may be reason for optimism.

Incentives for bushmeat consumption and importation among west african immigrants, Minnesota, USA

The knowledge, attitudes, and practices surrounding bushmeat consumption and importation in the United States are not well described. Focus groups of West African persons living in Minnesota, USA, found that perceived risks are low and unlikely to deter consumers. Incentives for importation and consumption were multifactorial in this community.